DSRU Education Testimonials2018-10-05T15:21:25+00:00

DSRU Education Testimonials

We asked some of our course delegates, postgraduate students and speakers about their experience of DSRU Education & Training. This is what they had to say about us…

 RAJ BASRAN

Associate Manager, Gilead Sciences

Raj studied for the Postgraduate Diploma in Pharmacovigilance with the DSRU.

Raj graduated from the University of Leicester with a Master of Molecular Pathology and Toxicology degree in 2004. Raj worked as a Clinical Research Assistant for a year before moving into his first role in pharmacovigilance as a Patient Safety Associate at AstraZeneca. Since then, Raj has had multiple roles within both Clinical Research and Pharmacovigilance before taking on a permanent role as a Senior Safety Specialist at Gilead Sciences.

With specialised experience in the production and quality management of individual case safety reports, Raj decided it was time to gain a broader knowledge of Pharmacovigilance to further develop his career. He learnt about the courses available with the DSRU from a number of colleagues and researched courses himself before deciding to study for a Postgraduate Diploma in Pharmacovigilance. Raj completed eight courses: Back to Basics in Pharmacovigilance, Introduction to Pharmacoepidemiology, Medical Aspects of ADRs, Pharmacovigilance Planning and Risk Management, Monitoring Safety in Clinical Trials and Drug Development, Periodic Safety Reports PSURs/PBRERs, Global Pharmacovigilance Regulatory Requirements: What’s New? and Risk Benefit Assessment in Pharmacovigilance.

Raj really enjoyed his training and the course in whole, so much so he took on the role as Student Representative. He received valuable support from the DSRU Education & Training Manager, Fiona Snelling, through the duration of the course. He found the courses to be excellent, with a fluid structure and a great selection of key speakers working within pharmacovigilance, be that from the pharmaceutical industry, academia or even regulatory authorities.

Raj feels that the course has been valuable to him as it has exposed him to new areas within pharmacovigilance. He has a better understanding of the industry as a whole and has grown in confidence. Since starting the course, Raj has been promoted to Associate Manager and now

PAWAN RISHIRAJ

Head of Drug Safety, UK & Ireland, Merck Serono LtD

Pav and his team, like their counterparts in all pharmaceutical companies, are responsible for ensuring that the benefit-risk profile for all company products remain both positive and favourable. Pav says that the “pharmacovigilance landscape is ever evolving through constant change twinned with tight regulations, which brings with it a lot of responsibility for ultimately ensuring patients continue to receive safe and effective medicines”. The pharmaceutical industry is one of the most stringent industries globally and Pharmacovigilance (Drug Safety) is therefore audit and inspection driven. To demonstrate compliance and due diligence it is essential that the team are current in their knowledge, which can be gained and demonstrated through training and certification.

Pav chooses to attend DSRU courses and conferences because DSRU always provide relevant, informative and constructive sessions. Pav says “it’s great because the DSRU engage the key stakeholders across the industry including regulators and academics and practicing industry experts to share common knowledge, refinements to current methods and techniques, and importantly transparent interpretation that should be applied in everyday practice”.

At the DSRU’s recent 8th Biennial Signal Detection conference these expert speakers and delegates included individuals working in the role of Head of Drug Safety at a number of pharmaceutical companies. They were all sharing their strategies, approaches, mindsets and challenges on particular areas which require that extension of thought and knowledge. Of course, speakers have some confidential material which they cannot disclose, but this “real-time perspective” provides the necessary insights to ensure companies are fulfilling their Pharmacovigilance obligations in a compliant fashion. Pav says that “when you put such great minds in a room discussing these subjects, intelligence is shared, and together optimal solutions materialise. Without such discussion and another validated opinion, one remains channelised and narrow. Sharing knowledge is a gain, and knowledge is power”. Pav quotes Albert Einstein by adding “We cannot solve our problems with the same thinking we used when we created them”.

Pav describes the DSRU as the front runners in pharmacovigilance training in the UK and perhaps in Europe. He says “they are oceans ahead of other course or seminar providers on relevance and with this in mind, invite some of the most important key stakeholders in both industry and regulatory authorities alike”. Engagement and the mere discussion of the legislation directly with the regulators, and being able to ask them face to face for their interpretation, is of enormous benefit and the outcomes can be considered for company adoption. This level of engagement means that Pav chooses to use DSRU for his own training and conference requirements and also for those of his team. Other than specific university offerings Pav does not use other pharmacovigilance training providers.

Pav also believes that the DSRU benefit from having Professor Saad Shakir, one of the most reputable professors in the discipline, leading their organisation. The content, structure, knowledge, chronology,and relevance of the DSRU training is very important to Pav. “The DSRU integrate the practical element to their training and discussion – now you have learned the theory from the experts’ perspective, try to apply it at a company level as best as possible.” Other training providers do not have this selective and relevant “expertise”.

The networking element is also a unique benefit when attending DSRU courses and conferences, and attendees have the opportunity to have intelligent discussions in an expert environment. Pav finished by saying “it would be unfavourable and intelligence-depriving not to attend these network dinners if you want to be at the forefront of PV intelligence within the crowd who are actually influencing, shaping, refining and mapping the future of our industry”.

KAREN PATTENDEN

Previously Senior Director, Drug Safety & Public Health, Gilead Sciences

Karen was responsible for all of the compliance metrics, standard operating procedures, review and interpretation of regulations, inspections, audits and all affiliate support work at Gilead Sciences. Gilead Sciences was founded in 1987 and develops therapies for HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases, and cardiovascular conditions. The organisation has experts working in many different disciplines with a focus to create products that will help patients. Gilead Sciences has bases in North and South America, Asia, Africa, Australia and 19 countries in Europe, with their International headquarters in the UK.

Karen’s team worked globally. They maintain the pharmacovigilance master file for Europe and prepare and administrate all of the pharmacovigilance and outsourced clinical trials licensing agreements for Gilead. The team also carry out all of the necessary affiliate support work and training with affiliates in local markets.

With such a global view and a wide remit within pharmacovigilance Karen sent a lot of her team members on DSRU pharmacovigilance and risk management training courses. Karen also attended as a course speaker from time to time to share her knowledge and expertise. The reason Karen chose DSRU over other training providers is the quality of the course content. She says ‘what you are getting is real and valid experience and not just a regurgitation of the regulations. Therefore you also get a good attendee base who participate and discuss the topics together, and share their own views and experience’. Karen says that is very different to other training providers who are not operating in the pharmacovigilance space. ‘DSRU are constantly scrutinising and changing and updating the content they present, and their speakers and presenters are actively engaged in pharmacovigilance work’

Another reason why Karen sent her staff to DSRU is the level of participation they are offered. She says that the DSRU actively encourage people to say what they want to know in an open training forum. There are many experts attending the courses and conferences and questions can also be opened up to the floor as well as to the presenters and speakers. This is a unique opportunity to discuss topics and views across a spectrum of knowledgeable practitioners and regulators. Karen says that even as a lecturer she picks up new views and information each time. Over the past few years the DSRU courses have become more and more interactive and Karen says ‘students love it’.

Karen loved the diversity of her role at Gilead and built a very strong and knowledgeable team.

DANIA SHAMIL

Senior Pharmacovigilance Regulations Specialist

Dania graduated from the University of London, School of Pharmacy with a Master of Pharmacy Degree in 2010 and registered with the General Pharmaceutical Council as a qualified pharmacist in 2011. Dania worked as a hospital pharmacist for two years that included her pre-registration year. Dania was soon after head-hunted to work as a pharmacist in the Home Healthcare Sector. As part of her role she was heavily involved in setting up the pharmacovigilance system and felt the postgraduate programme in pharmacovigilance offered by the DSRU would benefit the development of a career in pharmacovigilance as she was keen to be involved in ensuring patient safety by monitoring the adverse effects of marketed or investigational drugs.

Throughout the course Dania has enjoyed interacting and networking with her peers and expert faculty who work in the same industry. This inspired and motivated her to continue her career in pharmacovigilance.

As a direct result of starting the MSc in Pharmacovigilance with the DSRU, Dania was approached by numerous pharmaceutical companies who felt the qualification added years of experience to her profile, despite only having worked in pharmacovigilance for just over a year. This led to Dania’s first industry role of Senior Pharmacovigilance Associate, which involved centralising and managing pharmacovigilance systems in the UK affiliate.

This role gave Dania experience in working with the European Regulations in pharmacovigilance. The role involved ensuring that Individual Case Safety Reports (ICSRs) were in accordance with European regulations, preparing for pharmacovigilance internal and regulatory audits and inspections, maintenance of the Pharmacovigilance System Master File (PSMF) and managing partner/vendor contracts and pharmacovigilance agreements. Dania felt that all the knowledge she had learnt during the short courses was now being put into practice. Having gained this new knowledge and growing in confidence Dania completed the Post Graduate Diploma in Pharmacovigilance (PgD) award in 2015.

Having worked for a UK affiliate and grasping the day to day pharmacovigilance system concepts, Dania was offered the opportunity and decided that she wanted to move into more specialist role in pharmacovigilance compliance that would help with her career development. Dania is now working as a Senior Pharmacovigilance Regulations Specialist in the International Pharmacovigilance Regulations and Compliance team for a global pharmaceutical company.

Dania says “Without the Postgraduate Diploma in Pharmacovigilance behind me it would have been difficult to get into the industry as I did not have pharmaceutical industry experience. The qualification has been a talking point in all of my interviews and it has helped me immensely with my career journey thus far.”

Dania is now in the process of completing her Masters Research project, which she is thoroughly enjoying.

BINA PATEL

Pharmacovigilance Officer, Alcon, a Novartis Company

Bina qualified from Portsmouth University as a pharmacist in 2008 and started her career with Lloyds Pharmacy based in London. She subsequently married and moved to Guildford and began to seek out opportunities for expanding her career outside pharmacy. She was looking for wider opportunities within the pharmaceutical industry and also a better work-life balance. Bina said that working as a locum pharmacist involves very long shifts and unsociable hours.

Bina was looking for a career that would allow her to combine her skills as a pharmacist with wider pharma opportunities. She was interested in pharmacovigilance but noted that there seemed to be no structured entry mechanism or structured career progression within pharmacovigilance. She did a lot of reading and online research to find out more about pharmacovigilance and the opportunities within the discipline. Bina wanted to explore it further to find out if she would really like and enjoy a career in pharmacovigilance, and what the opportunities and roles were like within the discipline. She researched courses and chose to do four DSRU courses which she funded herself as an investment in her potential future career development.

Bina found DSRU by searching online, and when she contacted DSRU she found the training department and the organisation’s Education and Training Manager Becci Petch to be really helpful and supportive of her ambitions. Becci was able to answer the questions that Bina had and to give her clear and helpful advice on the best combination of courses to meet Bina’s needs. Bina completed four courses: Back to Basics in Pharmacovigilance, Pharmacovigilance Planning and Risk Management, Case Narrative Writing**, and Reviewing and Understanding Clinical Papers

Bina has really enjoyed her training. She said ‘the DSRU courses gave me a really good insight into what pharmacovigilance is about. Not only from the conference speakers and course lecturers, but from the other participants who are from all across the industry and have different perspectives on things and different approaches’. Bina said that the Risk Management Planning course isn’t necessarily for someone new to the field but it gave a great insight into what her future opportunities within pharmacovigilance could be. It wasn’t all about case processing. She developed a view of ‘where do you start, where can you go, what’s the career progression?’.

Bina also said that the DSRU courses were very helpful in preparing her for interviews, these were the first interviews she had ever done as even when she qualified she as already pre-registered with Lloyds so didn’t do any interviews. Alcon wanted someone that had a relevant background but that they could train up in pharmacovigilance. The fact that Bina had funded her own training and been really proactive about getting into pharmacovigilance was important to Alcon. With her background as a pharmacist Bina knew the products which was helpful, and Alcon also do medical devices which opens up even more doors for her. The pharmacovigilance team at Alcon is relatively small and so Bina is doing lots of different things and not just case processing.

Regarding the DSRU courses Bina said that the main benefit was a really good insight into pharmacovigilance. Practically the courses helped with her interviews, for example the risk benefit workshops were great for practical experience. The workshops in the Case Narrative Writing course were really useful as she was asked to write a narrative at interview so felt well prepared for that. Bina said that the DSRU speakers were very good at getting information across and that because the groups were small it was easy and comfortable to ask questions.

Bina concluded ‘I found the DSRU team lovely deal with and really helpful, and the courses were excellent. I would happily recommend DSRU courses to anyone considering changing career and moving into pharmacovigilance, or indeed enhancing their career within the discipline’.

**This course has been enhanced and is now called Assessment and Medical Evaluation of Individual Case Reports

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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